A Phase I First-in-human, Open-label Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0500, A Humanized GPRC5D-BCMA-CD3 Tri-specific Antibody, in Participants With Relapsed or Refractory Multiple Myeloma
Summary
This is an open-label, multicenter phase 1 clinical trial to evaluate the safety and tolerability, efficacy, and pharmacokinetics of SIM0500 in adult participants with Relapsed or Refractory Multiple Myeloma(RRMM). The trial is consisted of two parts, Part 1 (dose escalation) and Part 2 (dose optimization). In both parts, SIM0500 will be administered until disease progression, intolerable toxicity, withdraw of consent or end of trial.
Arms & interventions
- DrugSIM0500
Participants will receive SIM0500 in a 28-day cycle until disease progression, intolerable toxicity, or until the participant voluntarily withdraws from trial intervention, or end of study, whichever comes first.
Outcome measures
Primary
Dose-limiting toxicity (DLT)
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Eligibility criteria
Study locations (6)
Mayo Clinic Arizona
Phoenix, Arizona, 85054
Mayo Clinic Florida
Jacksonville, Florida, 32224
Dana Farber Cancer institution
Boston, Massachusetts, 02215
Mayo Clinic Rochester
Rochester, Minnesota, 55905
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, 10016
Icahn School of Medicine at Mount Sinai,The Tisch Cancer Institute
New York, New York, 10029